Simponi (golimumab) is a human monoclonal antibody for TNF-α. It is approved for treatment of moderate to severe rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (in monotherapy or in combination with methotrexate), and spondylarthritis (in monotherapy). It is given as a subcutaneous injection once a month on the same date, at a dose of 50 mg.
Simponi has been compared with placebo in treatment of active rheumatoid arthritis (RA) in both patients who are non-respondant to methotrexate (MTX) treatment, and patients who have not experienced any beneficial effects when being treated with MTX or other TNFα-inhibitors. Patients treated with Simponi experience either a minimal response (ACR20) after 14 weeks of treatment, or a moderate response (ACR50) after 50 weeks of treatment, significantly more often than patients treated with placebo. Simponi has also shown a better effect than placebo for its other indications.
Results regarding progression of structural changes in the joints are not yet available.
Golimumab has neither been compared to other TNFα-inhibitors nor other biological antirheumatics.
The most commonly occurring side effects are infections (especially in the upper respiratory passages) and infestations. Long-term side effects are, for the time being, unknown.
The price for a year of treatment with Simponi is about 16.000 D.kr. (AIP).
IRF finds that TNFα-inhibitors still are the top choice among the biological antirheumatics. The choice of TNFα-inhibitor should be made with a background knowledge and experience with the products, especially concerning long-term effects and long-term side effects. Because of this, Enbrel, Humira and Remicade must still be considered the most obvious choices for a first line agent. Simponi is a new TNFα-inhibitor, and could – with background in an advantageous comparison with one of the old TNFα-inhibitors – have secured a foothold in the row of first line agents. This comparison, however, has not been made, which is why Simponi’s potential advantages in respect to other TNFα-inhibitors are hard to identify. As a result of this, Simponi is not an obvious choice of first line agent in biological treatment of RA. Simponi is better than placebo in treatment of patients, whose treatment with other TNFα-inhibitors have failed, which is why it could be tried in this type of situation.
Simponi was marketed on the 16th of November 2009.